EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2017/1539 Rev1 
(POOL/E2/2017/1539/1539 -R1-
EN.docx) D092049/02  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) 2023/915 as regards maximum levels of deoxynivalenol in 
food  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EU) 2023/915 as regards maximum levels of deoxynivalenol in 
food  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Council Regulation (EEC) No  315/93 of 8  February 1993 laying down 
Community procedures for contaminants in food1, and in particular Article  2(3) thereof,  
Whereas:  
(1) Commi ssion Regulation (E U) 2023/9152 sets maximum levels for certain 
contaminants , including deoxynivalenol (DON) in food.  
(2) In 20 17, the European Food Safety Authori ty (‘the Authority’) adopted a scientific 
opinion on the risks to human and animal health related to the presence of 
deoxynivalenol and its acetylated and modified forms in food and feed3. The Authority 
concluded in that opinion that the tolerable daily intake (TDI) of 1 µg/kg body weight 
(bw) per day for DON, was to be considered as a group -TDI for the sum of DON, 3 -
acetyl -deoxynivalenol (3 -Ac-DON), 15 -acetyl -deoxynivalenol (15 -Ac-DON) and 
deoxynivalenol -3-glucoside  (DON -3-glucoside). In order to assess acute human health 
risk, a group acute reference dose ( ARfD) of 8 µg/kg bw per eating occasion was 
calculated. Estimates of acute  dietary exposures were below this dose and did not raise 
a health concern in humans. However, t he estimated  mean chronic dietary exposure s 
were  above the group -TDI in infants, toddlers  and other children, and at  high 
exposure s also in adolescents and adults, indicating a potential health concern.  
(3) In light of the Authority’s opinion, t he Commission has considered the possibility of 
setting maximum levels for the sum of DON, 3 -Ac-DON, 15 -Ac-DON and DON -3-
glucoside. However given the limited amount of occurrence data for the sum of DON, 
3-Ac-DON, 15 -Ac-DON and DON -3-glucoside  and given that 3-Ac-DON, 15 -Ac-
DON and in particular DON -3-glucoside  are not yet analysed on a routine basis,  there  
is insufficient information at this time to set such maximum levels until the method of 
analysis for the routine analysis of the acetylated and modified forms of DON is 
further develop ed and the presence of the sum of DON and its acetylated and modified 
forms  is monitored . In the meantime, in order to ensure a high level of publ ic health 
 
1 OJ L 37, 13.2.1993, p. 1.  
2 Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants 
in food and repealing  Regulation (EC) No 1881/2006 (OJ L 119, 5.5.2023, p. 103).  
3 Scientific  opinion on the risks to human and animal health related to the presence of deoxynivalenol 
and its  acetylated and modified forms in food and feed. EFSA Journal 2017;15(9):4718 , 
https://doi.org/10.2903/j.efsa.2017.4718 .    
  
EN 2  EN protection, it is appropriate to lower certain existing maximum levels for DON 
following the principle that maximum levels are to  be set at a level as low as 
reasonably achievable by  applying good practices to minimize contamination  and 
thereby taking into account recent occurrence data.  
(4) In order to ensure that good agricultural practices are applied to minimize the presence 
of DON  in cereals , it is important to lay down a  maximum level for unprocessed 
cereals. As unprocessed oats, before milling  or before being used in cereal products 
placed on the market for the final consumer , are placed on the market with the husk, 
the maximum level for DON in unprocessed oat  grains  should apply to the 
unprocessed oat  grains with the husk included, even if the husk is inedible.   
(5) Regulation (E U) 2023/915  should therefore be amended accordingly.  
(6) It is appropriate  to provide for a transitional period for food lawfully placed on the 
market before the date of application of this R egulation  taking into account that certain 
foods covered by this Regulation have a long shelf life.   
(7) To enable economic operators to prepare for the new rules introduced by this 
Regulation, it is appropriate to provide for a reasonable time until the new maximum 
levels apply .  
(8) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex I to Regulation (E U) 2023/915  is amended in accordance with the Annex to this 
Regulation.  
Article 2   
Food listed in the Annex , lawfully placed on the market before 1 July 2024, may remain on 
the market  until their date of minimum durability or use -by date.   
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from 1 July 2024.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN